Abstract
In a multicenter, randomized, investigator-blind, parallel study, 398 patients were dispensed topical butoconazole nitrate 2% cream for 3 days (n = 199) or miconazole nitrate 2% cream for 7 days (n = 199) for vaginal use. Efficacy analyses included 254 patients with culture-confirmed Candida (119 butoconazole and 135 miconazole users). Of the 398 patients issued study medication, 9 were lost to follow-up. Therefore, safety analyses included 389 patients (197 butoconazole and 192 miconazole users). Evaluations upon admission and approximately 8 and 30 days post-treatment included Candida cultures, potassium hydroxide (KOH) wet mounts, and vulvovaginal examinations, with rating of vulvovaginal signs and symptoms using a 4-point scale. Rates of clinical cure (based on sign/symptom scores), microbiologic cure (based on cultures and wet mounts), and therapeutic cure (both clinical and microbiologic cures) were assessed and were to be similar between the regimens. Therapeutic cure rates were 57.8% and 61.4% for butoconazole and miconazole, respectively. Three-day butoconazole treatment was as safe and effective as 7-day miconazole therapy in treating vulvovaginal candidiasis. Infect. Dis. Obstet. Gynecol. 4:323–328, 1996. © 1997 Wiley-Liss, Inc.
Highlights
The primary objective of this study was to compare the effectiveness and safety of 3-day butoconazole with 7-day miconazole treatments in women with vulvovaginal candidiasis
Butoconazole nitrate was presented to patients in one box containing 3 applicators prefilled with butoconazole nitrate cream
Patients admitted to the trial were generally healthy women with pseudohyphae on potassium hydroxide (KOH) wet mount, which was confirmed by a positive Candida culture
Summary
The primary objective of this study was to compare the effectiveness and safety of 3-day butoconazole with 7-day miconazole treatments in women with vulvovaginal candidiasis. Therapeutic, microbiologic, and clinical cure rates were determined after consecutive daily intravaginal treatment with either butoconazole nitrate 2% cream (3 days) or miconazole nitrate 2% cream (7 days). Enrolled patients signed an informed consent and agreed to abstain from sexual intercourse during the treatment period and to use condoms for the remainder of the study period During the study they agreed to abstain from using any vaginal product containing nonoxynol-9, vaginal douches, other vaginal or vulvar topical therapeutics, vaginal contraceptives, or feminine sprays. Vulvovaginal signs (erythema, swelling, excoriation, ulceration) and symptoms (burning, itching) were recorded and rated on a 4-point scale (0 none; mild; 2 moderate; 3 severe). Clinical response was assessed at both follow-up visits on the basis of presence or absence of vulvovaginal signs/symptoms (e.g., burning, itching, erythema, swelling, excoriation, and ulceration) rated on a 4-point categorical scale (i.e., 0 none; mild; 2 moderate; 3 severe). Any patient who was not clinically cured at the first follow-up visit was excluded from the clinical cure rate analysis at the second follow-up visit
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